JP2019515764A - 流体を肺系に供給するための液滴送達装置、及びその使用方法 - Google Patents
流体を肺系に供給するための液滴送達装置、及びその使用方法 Download PDFInfo
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Abstract
Description
[0001] 本出願は、2016年5月3日に出願された「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE」と題する米国仮特許出願第62/331,328号、2016年5月5日に出願された「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE」と題する米国仮特許出願第62/332,352号、2016年5月10日に出願された「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE」と題する米国仮特許出願第62/334,076号、2016年6月24日に出願された「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE」と題する米国仮特許出願第62/354,437号、2016年9月23日に出願された「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE」と題する米国仮特許出願第62/399,091号、2016年11月1日に出願された「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE」と題する米国仮特許出願第62/416,026号、 2016年11月16日に出願された「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE」と題する米国仮特許出願第62/422,932号、2016年12月1日に出願された「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE」と題する米国仮特許出願第62/428,696号;2017年1月20日に出願された「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE」と題する米国仮特許出願第62/448,796号、及び2017年3月15日に出願された「DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE」と題する米国仮特許出願第62/471,929号について、米国特許法第119条に基づく優先権を主張する。各出願の内容は、その全体が参照により本明細書に組み込まれる。
Ec=t−CL
Den=2(Ec)+Dex
実施例A:自動呼吸作動
[0191] 図1B〜図1Eを参照すると、本開示の液滴送達装置構成は、噴出器機構の自動呼吸作動および自動スプレー検証を提供する様々なセンサ適応を含めて提供している。センサは、患者の吸入サイクルのピーク時にエアロゾルプルームの作動を引き起こす。特定の実施において、患者の吸入のピーク期間の調整は、患者の肺気道へのエアロゾルプルームの最適な堆積および関連する薬物送達を確実にし得る。多様な配置が可能であるが、図1Bは、例示的なセンサ構成を示している。 Sensirion(www.sensirion.com)のSDPxシリーズ(SDP31又はSDP3s圧力センサ)が使用され得る。
[0192] アンダーセンカスケードインパクタ試験、総薬物質量出力速度、総薬物呼吸可能質量、送達効率、及び再現性を含む、本開示の例示的な液滴送達装置について、液滴サイズ分布および関連機能性を評価した。図21A〜21Fは試験結果の要約を提供する。
[0193] Pneuma(米国商標)吸入器装置を使用してエアロゾルの特徴および硫酸アルブテロールの送達量を評価するためにARE Labs, Inc.で研究が行われた。この研究は、単一のPneuma(米国商標)吸入器の装置性能を評価するために設計された。各試験について新しい使い捨て薬物カートリッジを用いて一連の3つの個別試験を行った。試験プラットフォームは、流速測定のために較正されたAALBORGモデルGFM47質量流量計(AALBORG Instruments and Controls; Orangeburg、NY)を備えた8段階ノンバイアブル(nonviable)アンダーセンカスケードインパクタ(Thermo Fisher Scientific; Waltham、MA)を利用する。バルブ付きGastロータリーベイン真空ポンプ(Gast Manufacturing, Benton Harbor, MI)を使用して
[0199] 全ての薬物含有量分析は、マイクロフローセル(75μm×10mm光路長、総分析容量44.2nl)を用いたDionex UVD−3000多波長UV/VIS検出器を備えたDionex Ultimate 3000ナノHPLCを使用して実施した。硫酸アルブテロールに使用したカラムは、186バールの公称圧力で6μl/分のカラム流速を有するPhenomenex Luna(内径0.3mm×150mm)C18,100A(USP L1)カラムであった。全HPLC実行時間は、サンプルあたり6分で、各サンプルの間に約5分のフラッシュをした。サンプル注入は、フルループ(Full loop)注入モードで1μlのサンプルループを用いて行った。硫酸アルブテロールについては276nmのUVで検出した。
[0200] 硫酸アルブテロールの分析のための参照方法として、米国薬局方モノグラフUSP29nf24s_ms1218に従った。手短に言えば、この方法は、移動相中の硫酸アルブテロールの適切な製剤の希釈を含んでいた(60%緩衝液および40%HPLCグレードメタノール(Acros Organics))。緩衝液製剤は、2mlの氷酢酸(Acros Organics)を加えた1200mlの水中の1.13grの1-ヘキサンスルホン酸ナトリウム(Alfa Aesar)を含む逆浸透濾過脱イオン水を含む。移動相溶液を混合し、そして0.45μmフィルタ膜を通して濾過した。最終移動相は、緩衝液:MEOHの60:40希釈液である。
[0201] 吸入薬充填量、総送達量、経過粒子投与量、経過粒子割合、呼吸可能粒子投与量、呼吸可能粒子割合、微粒子投与量、微粒子割合;エアロゾルMMADおよびGSDの各成分について、3回の反復試験セットすべてに対して平均および標準偏差を計算した。すべてのデータセットに対して95%の信頼水準を示すように試行回数がもたらされた。
[0202] 以下の表は、アンダーセンカスケードインパクタ試験の各液滴サイズ段階(Albuterol、0.5%、アンダーセンカスケード、28.3lpm、10回の作動)で収集された液滴の質量分率の要約を示している。示されるように、約5μm未満の平均直径の液滴の75%超、および約4μm未満の平均直径の液滴の70%超がある。
[0205] 本開示の液滴送達装置を2つの基本的な装置、コンビベント(米国登録商標)レスピマット(米国登録商標)吸入器(Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield CT)、及びPROAIR(米国登録商標)FHA(Teva Respratory, LLC Frazer, PA)と評価および比較するためにインビトロ研究を行った。まず、図22A、図22Bを参照すると、本開示の液滴送達装置(試験装置)およびレスピマットソフトミスト(米国登録商標)吸入器から生成されたエアロゾルプルームの比較が示されている。図22Aにおいて、試験装置によって生成されたエアロゾルプルームは、層流(1)乱流(2)に関連する2つの異なる流れパターンを有する。本明細書で前述したように、液滴が5μm未満のMMAD直径を有し、同伴空気の発生を招くと、乱流および渦電流の形成が生じる。これとは対照的に、図22Bにおいて、レスピマットソフトミスト(米国登録商標)吸入器によって形成されたプルームは、高い運動量および運動エネルギを有する、高速度および広範囲の液滴サイズを有する液滴が特徴的であることを示している。
[0214] 本開示の例示的な噴出器装置(試験装置)を使用して、慢性閉塞性肺疾患を有する患者のグループにおいて、硫酸アルブテロールおよび臭化イプラトロピウムを使用した試験装置の急性気管支拡張作用と無治療とを比較するクロスオーバー臨床試験を実施した。
[0222] 本開示の例示的な液滴送達装置(試験装置)を使用して、慢性閉塞性肺疾患(COPD)の患者のグループにおける硫酸アルブテロールを使用した、試験装置対プロエア(米国登録商標)HFA吸入器の急性気管支拡張作用を比較するクロスオーバー臨床試験を実施した。
[0230] 本開示の例示的な液滴送達装置を使用して、上皮成長因子受容体(EGFR)モノクローナル抗体、ベバシズマブ(アバスチン)、アダリムマブ(ヒュミラ)、及びエタネルセプト(エンブレル)を含む大分子が、本開示の装置を通じた放出によって変性したり劣化したりすることはなく、局所的な肺への送達および/または活性剤の全身への送達が達成されることを検証するために試験を行う。
[0234] 図24A〜24Bを参照すると、作動後に試験装置から収集された、4:1に希釈されたエンブレル(米国登録商標)(10mg/ml)対照(図24A)およびエアロゾル化Enbrel溶液(図24B)のSECクロマトグラフである。単一の主ピークが、約25分の溶出時間でエアロゾル化されたエンブレル溶液のクロマトグラフにおいて明らかである。以下の表は、対照およびエアロゾル化エンブレル溶液について、特定の溶出時間(分)で出現するさまざまなピークについてのUV曲線下面積を比較したものである。
[0244] 図25A、図25Bを参照すると、対照としてのKwikpenからのインスリンのSECクロマトグラフ(200U/ml;34.7mcg/U;6.94mg/ml)(図25A)と、試験装置からエアロゾル化されたインスリンのSECクロマトグラフとである(図25B)。作動後、約150mclのエアロゾル化インスリン溶液を試験装置から集めた。単一の主ピークは、エアロゾル化インスリン溶液のクロマトグラフにおいて明らかであり、溶出時間は約25分である。以下の表は、対照およびエアロゾル化インスリン溶液について特定の溶出時間で出現する様々なピークについてのUV曲線下面積を比較する。保持時間は数分である。
エアロゾル化した抗体またはタンパク質の活性は、細胞表面上のその抗原または標的に結合するその能力、すなわちEGFR、TNFαなどを試験することによって実証される。エアロゾル化または非エアロゾル化活性剤のいずれかと共にインキュベートされた細胞のフローサイトメトリーデータは活性を反映するであろう。具体的には、データは、未処理細胞に対するものと比較して、非エアロゾル化蛍光標識活性剤と共にインキュベートされた細胞の蛍光強度のシフトを示すであろう。エアロゾル化活性剤とインキュベートした細胞でも同様のシフトが得られ、エアロゾル化後の活性剤はその免疫活性、したがって細胞表面上のその標的受容体に結合する能力を保持していることが示唆される。
概して図1A〜1Eに示される本開示の例示的な噴出器装置を使用して、大分子活性剤の投与後の薬物動態データを評価するために臨床試験が行われている。pKデータは、高分子活性剤が体系的に投与されたことを証明するであろう。
Claims (20)
- 対象者の肺系に液滴の放出流として流体を送達するための圧電作動される液滴送達装置であって、
ハウジングと、
一定量の流体を受容するために、前記ハウジング内に又は前記ハウジングと流体連通するように配置された貯蔵部と、
圧電アクチュエータ及びアパーチャプレートを備える噴出器機構であって、前記アパーチャプレートは、その厚さを通して形成された複数の開口を有し、前記圧電アクチュエータは、前記アパーチャプレートを振動させて液滴の放出流を生成する、噴出器機構と、
前記ハウジング内に配置された少なくとも1つの差圧センサと、
を備え、
前記少なくとも1つの差圧センサは、前記ハウジング内の所定の圧力変化を感知すると前記噴出器機構を作動させ、それにより液滴の放出流を生成するように構成され、
前記噴出器機構は、液滴の放出流の質量の少なくとも約70%が、使用中に対象者の肺系に呼吸に適した範囲で送達されるように、少なくとも約70%の前記液滴が約5ミクロン未満の平均放出液滴直径を有する液滴の放出流を生成するように構成される、液滴送達装置。 - 前記アパーチャプレートと前記貯蔵部との間に表面張力プレートを更に備え、前記表面張力プレートは、前記一定量の流体と前記アパーチャプレートとの接触を増加させるように構成される、請求項1に記載の液滴送達装置。
- 前記噴出器機構と前記表面張力プレートとが平行な向きに構成されている、請求項2に記載の液滴送達装置。
- 前記表面張力プレートは、前記表面張力プレートと前記アパーチャプレートの間に毛細管流動を提供するのに十分な静水圧を生じさせるように前記アパーチャプレートの2mm以内に配置される、請求項3に記載の液滴送達装置。
- 前記アパーチャプレートがドーム型形状を備える、請求項1に記載の液滴送達装置。
- 前記アパーチャプレートが、ポリエーテルエーテルケトン(PEEK)、ポリイミド、ポリエーテルイミド、ポリフッ化ビニリデン(PVDF)、超高分子量ポリエチレン(UHMWPE)、Ni、NiCo、Pd、Pt、NiPd、合金、及びそれらの組み合わせからなるグループから選択される材料から構成される、請求項1に記載の液滴送達装置。
- 前記複数の開口のうちの1つ以上が異なる断面形状または直径を有し、それにより異なる平均放出液滴直径を有する放出液滴を提供する、請求項1に記載の液滴送達装置。
- 前記ハウジングの前記空気流入口側に配置された層流要素であって、前記アパーチャプレートの前記出口側を横切る層流を促進し、使用中に前記液滴送達装置を通って前記液滴の放出流が流れることを保証するのに十分な空気流を提供するように構成された層流要素を更に備える、請求項1に記載の液滴送達装置。
- 前記層流要素の反対側で前記ハウジングと結合されたマウスピースを更に備える、請求項8に記載の液滴送達装置。
- 前記噴出器機構は、前記ハウジングから排出される前に、前記液滴の放出流が約90度軌跡を変化して前記ハウジングの中へ及び当該ハウジングを通って導かれるように前記ハウジングに関して方向付けられる、請求項1に記載の液滴送達装置。
- 前記貯蔵部が前記ハウジングと取り外し可能に結合されている、請求項1に記載の液滴送達装置。
- 貯蔵部が前記噴出器機構に結合されて結合貯蔵部/噴出器機構モジュールを形成し、前記結合貯蔵部/噴出器機構モジュールが前記ハウジングと取り外し可能に結合されている、請求項1に記載の液滴送達装置。
- 無線通信モジュールを更に備える、請求項1に記載の液滴送達装置。
- 前記無線通信モジュールは、Bluetooth送信機である、請求項13に記載の液滴送達装置。
- 前記装置が、赤外線送信機、光検出器、追加の圧力センサ、及びそれらの組み合わせから選択される1つ又は複数のセンサを更に備える、請求項1に記載の液滴送達装置。
- 対象者の肺系に液滴の放出流として流体を送達するための呼吸作動式の液滴送達装置であって、
ハウジングと、
一定量の流体を受容して液滴の放出流を生成するために、前記ハウジングと流体連通するように配置された結合貯蔵部/噴出器機構モジュールと、
圧電アクチュエータ、及びドーム型形状を有するアパーチャプレートを備える前記噴出器機構であって、前記アパーチャプレートは、その厚さを通して形成された複数の開口を有し、前記圧電アクチュエータは、前記アパーチャプレートを振動させて液滴の放出流を生成する、前記噴出器機構と、
前記ハウジング内に配置された少なくとも1つの差圧センサと、
を備え、
前記少なくとも1つの差圧センサは、対象者が前記ハウジングの気流出口側に吸息をもたらしたときに前記ハウジング内の所定の圧力変化を感知すると、前記噴出器機構を作動させて前記液滴の放出流を生成するように構成され、
前記噴出器機構は、液滴の放出流の質量の少なくとも約70%が、使用中に前記対象者の肺系に呼吸に適した範囲で送達されるように、少なくとも約70%の前記液滴が約5ミクロン未満の平均放出液滴直径を有する液滴の放出流を生成するように構成される、液滴送達装置。 - 前記ドーム型形状のアパーチャプレートが、ポリエーテルエーテルケトン(PEEK)、ポリイミド、ポリエーテルイミド、ポリフッ化ビニリデン(PVDF)、超高分子量ポリエチレン(UHMWPE)、Ni、NiCo、Pd、Pt、NiPd、合金、及びそれらの組み合わせからなるグループから選択される材料から構成される、請求項1に記載の液滴送達装置。
- 前記ハウジングの空気流入口側に配置された層流要素であって、前記アパーチャプレートの前記出口側を横切る層流を促進し、使用中に前記液滴送達装置を通って前記液滴の放出流が流れることを保証するのに十分な空気流を提供するように構成された層流要素を更に備える、請求項16に記載の液滴送達装置。
- 前記層流要素の反対側で前記ハウジングと結合されたマウスピースを更に備える、請求項16に記載の液滴送達装置。
- 慣性力を用いてエアロゾル化プルームから大きな液滴を濾過する方法であって、
請求項1に記載の液滴送達装置を用いて液滴の放出流を生成するステップを含み、
前記噴出器機構は、前記ハウジングから排出される前に、前記液滴の放出流が約90度軌跡を変化して前記ハウジングの中へ及び当該ハウジングを通って導かれるように前記ハウジングに関して方向付けられ、
約5μmよりも大きい直径を有する液滴が、慣性力により、前記液滴送達装置を通って出る同伴空気流中で対象者の肺系に運ばれることなく前記ハウジングの側壁に堆積する、方法。
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